During the first year after a heart transplant, people often rapidly lose bone from their
spine and hips. About 35 percent of people who receive heart transplants will suffer broken
bones during the first year after transplantation. This study will compare the safety and
effectiveness of the drug alendronate (Fosamax) and the active form of vitamin D
(calcitriol) in preventing bone loss at the spine and hip after a heart transplant.
In this study, people who have had a successful heart transplant will receive either active
alendronate and a "dummy pill" instead of calcitriol, or active calcitriol and a dummy pill
instead of alendronate for the first year after their transplant, starting within 1 month
after transplant surgery. We will measure bone density in the hip and spine at the start of
the study and after 6 and 12 months, and will also check for broken bones in the spine. This
research should lead to ways of preventing this crippling form of osteoporosis.

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Phase 3

During the first year after a heart transplant, people often rapidly lose bone from their
spine and hips. About 35 percent of people who receive heart transplants will suffer broken
bones during the first year after transplantation. This study will compare the safety and
effectiveness of the drug alendronate (Fosamax) and the active form of vitamin D
(calcitriol) in preventing bone loss at the spine and hip after a heart transplant.
In this study, people who have had a successful heart transplant will receive either active
alendronate and a "dummy pill" instead of calcitriol, or active calcitriol and a dummy pill
instead of alendronate for the first year after their transplant, starting within 1 month
after transplant surgery. We will measure bone density in the hip and spine at the start of
the study and after 6 and 12 months, and will also check for broken bones in the spine. This
research should lead to ways of preventing this crippling form of osteoporosis.

During the first year after a heart transplant, people often rapidly lose bone from their
spine and hips. About 35 percent of people who receive heart transplants will suffer broken
bones during the first year after transplantation. This study will compare the safety and
effectiveness of the drug alendronate (Fosamax) and the active form of vitamin D
(calcitriol) in preventing bone loss at the spine and hip after a heart transplant.
In this study, people who have had a successful heart transplant will receive either active
alendronate and a "dummy pill" instead of calcitriol, or active calcitriol and a dummy pill
instead of alendronate for the first year after their transplant, starting within 1 month
after transplant surgery. We will measure bone density in the hip and spine at the start of
the study and after 6 and 12 months, and will also check for broken bones in the spine. This
research should lead to ways of preventing this crippling form of osteoporosis.

To determine whether regular administration of lipid modifying drugs (clofibrate, nicotinic
acid, estrogen, dextrothyroxine) to men with a documented myocardial infarction would result
in significant reduction in total mortality over a five year period. Secondarily, to
determine whether the degree to which these drugs changed serum lipids was correlated with
any effect on mortality and morbidity rates; to gain further information on the long-term
prognosis of myocardial infarction (by studying the control group as intensively as the
treatment group); to acquire further experience and knowledge concerning the techniques and
methodology of long-term clinical trials; to determine, in a substudy, the effectiveness of
aspirin, a platelet inhibitor, in reducing recurrences of myocardial infarction.

To determine for a group of men at high risk of death from coronary heart disease whether a
special intervention program to lower serum cholesterol, reduce blood pressure, and
eliminate cigarette smoking would result in a significant reduction in mortality from
coronary heart disease.

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